To ensure that all raw materials, in-process products, and finished pharmaceutical products meet the required quality standards in compliance with regulatory guidelines, GMP requirements, and company quality policies.
Key Responsibilities
Perform routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
Ensure compliance with Good Manufacturing Practices (GMP), GLP, and regulatory requirements (e.g., NAFDAC, WHO, FDA where applicable).
Conduct chemical, physical, and instrumental analysis using equipment such as HPLC, GC, UV Spectrophotometer, and dissolution apparatus.
Review and interpret analytical data and ensure accurate documentation of results.
Prepare and standardize reagents, solutions, and volumetric standards.
Maintain laboratory instruments and ensure calibration and validation are carried out as per schedule.
Participate in method validation, method transfer, and verification activities.
Investigate Out of Specification (OOS), Out of Trend (OOT), and deviations, and support root cause analysis and CAPA implementation.
Ensure proper documentation in line with data integrity principles (ALCOA+).
Maintain laboratory cleanliness and adhere to safety procedures.
Support internal and external audits, including regulatory inspections.
Prepare Certificates of Analysis (CoA) and ensure timely release of materials/products.
Qualifications & Experience
Bachelor's degree in chemistry, Biochemistry, or related field.
Minimum of 5 - 8 years' experience in a pharmaceutical manufacturing environment.
Strong knowledge of analytical techniques and laboratory instruments.
Good understanding of GMP, GLP, and regulatory requirements (NAFDAC, WHO).